Clinical trial · Interventional
Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer
NCT01380808CI-TRIAL-00011488completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine and pseudomonas aeruginosa combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental arm
- description
- capecitabine and pseudomonas aeruginosa combination
- interventionNames
- Drug: capecitabine and pseudomonas aeruginosa combination
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- overall response rate
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female between 18 and 70 years old 2. Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally. 3. Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative) 4. Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy 5. Patients previously treated by capecitabine containing regimen should response to the chemotherapy containing capecitabine and progressed at least 4 months after the last capecitabine treatment 6. Karnofsky score more than 70;ECOG 0\~2; 7. Normal functions with heart, liver,renal and bone marrow 8. WBC≥4×109/L;Hb≥90 g/L;plt≥100×109/L 9. Got ICF before enrollment Exclusion Criteria: 1. Pregnant or breast-feeding women or positive serum pregnancy test 2. Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling 3. Participation in any investigational drug study within 4 weeks preceding treatment start. 4. Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer. 5. Serious uncontrolled intercurrent infections 6. Poor compliance
References
Publications (1)
- DERIVEDLv F, Cao J, Liu Z, Wang Z, Zhang J, Zhang S, Wang L, Zhao X, Shao Z, Wang B, Hu X. Phase II study of Pseudomonas aeruginosa-Mannose-Sensitive hemagglutinin in combination with capecitabine for Her-2-negative metastatic breast cancer pretreated with anthracycline and taxane. PLoS One. 2015 Mar 13;10(3):e0118607. doi: 10.1371/journal.pone.0118607. eCollection 2015. PMID 25768439